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By Scott Burris

Working with Corey Davis of the Network for Public Health Law, PHLR has completed and posted updated longitudinal datasets of state laws authorizing naloxone distribution and creating “Good Samaritan” immunity for callers reporting a drug overdose to 911. Take a look at www.lawatlas.org.

On the theory that an image beats a few hundred words, here’s a report on the state of the law:

The rising public and legislative awareness of opioid overdose has been a case study in the twists and turns of culture, risk perception and the role of evidence in policy making. An interesting case study, which does not mean I understand what happened or why.

I first got involved in overdose through Dan Abrahamson, the Legal Director at the Drug Policy Alliance. This was back in 1999 or 2000, and a group of drug researchers and drug policy people convened a meeting in Seattle to discuss the chronic, neglected problem of overdose among heroin users. There were a few health people who were highly aware of the human and economic costs, and the scale of the problem. Karl Sporer, a San Francisco ER doc, was one of the few publishing on the problem. One of the interesting ideas discussed at the meeting was distributing naloxone, the standard antidote for opioid overdose, directly to heroin users. New Mexico, which had the nation’s highest OD death rates, was trying it as a way to deal with the great distances that divided rural heroin users from EMS assistance. With Joanna Norland and Brian Edlin, I ended up writing an analysis of the legality of distributing this prescription drug to drug users.

In the next few years, led by people like Dan Bigg of the Chicago Recovery Alliance, needle exchange programs in urban areas began naloxone programs. They were spurred in 2006 when several US cities experienced an epidemic of overdose tied to the adulteration of the heroin supply with a synthetic opioid, fentanyl. By May, 2009, 57 naloxone programs were operating in 17 U.S. states. That year, DPA funded a group of scientists and practitioners to brainstorm on how to increase drug users’ access to this life-saving intervention. Continue reading →

I am not disputing the value of properly trained health professionals acting as gate-keepers to potentially dangerous drugs. And I am not taking on here the question of which health care professionals should be allowed to prescribe which drugs, though that is an important question on which the states vary quite a bit. Right now, though, there are at least three examples of important, even life-saving medicine that is being kept from people who need it because of rigid (or rigid interpretations of) state prescribing law, and the inability of the FDA to move quickly when its labeling no longer seems to meet the public interest:

1) Epinephrine (in epi-pens) to treat severe allergic reactions. Here’s a good story about that, highlighting a tragic case in which a child died because a school nurse would not or could not use epinephrine that had been prescribed for a different child. The story reports that 30 states now allow “undesignated” epinephrine to be used in these cases, but only four require it – and 20 still prohibit it.

2) Naloxone to prevent death from drug overdose. Naloxone is the standard treatment to reverse opioid overdose. People usually suffer OD far away from a doctor, but often in the presence of someone who could administer naloxone by simple intramuscular injection or intranasal spray. This year there has been quite a bit of legislative activity to break down this barrier to life-saving treatment, including a new bill passing both houses in California this week. But only 16 states and the District of Columbia have acted so far.

3) Expedited partner therapy for treatment of STDs. It takes at least two people to get an STD, or prevent one, but often only one partner is seeing the doctor. EPT gives the patient an extra prescription or dose for the partner. According to the CDC, this is still illegal in six states and not clearly legal in 9, the District of Columbia and Puerto Rico.

There is evidence for the safety and effectiveness of all these practices, and has been for years. Why does it have to take so long for state prescribing rules, or FDA labels, to change? We need a faster mechanism for keeing prescribing rules consistent with current practice and evidence. This is, after all, a matter of everyday life and death.

Training lay people to reverse opiate overdose with naloxone continues to gain steam in the evidence base, popular media and legislatures. Here’s a great blog post the covers recent developments and links to a new film. The Open Society Foundations and a group of harm reduction groups have launched a new website to promote these interventions.

This morning the House Energy & Commerce Health Subcommittee held the first of a series of hearings on prescription drug abuse. ONDCP Director Kerlikowske & Dr. Doug Throckmorton of FDA have both testified and both discussed naloxone.

Meanwhile, last week, Vermont became the 13th state to pass a law expanding lay access to naloxone.

Start with the sad news of the week. Dave Purchase died, aged 73. Dave was the father of needle exchange in the US, which as far as anyone can say started with Dave and a TV tray in disregard of Oregon’s drug paraphernalia law. Dave was a father figure to a whole generation (or two) of harm reduction advocates and providers. The Times obituary hits the key points in his life story, but not the calm moral force he brought to the movement. He was a man who did the right thing, modestly and steadily, and inspired others to do the same. He saved more lives than most people ever will, and had more friends. We’ll miss him.

On the good news front, Dave would have been happy to spread the word about the latest study on overdose programs using naloxone. Alex Walley and colleagues from Massachusetts reported this week in the British Medical Journal on the effects of the Massachusetts program. Between 2006 and 2009, six community overdose programs were launched to teach potential bystanders about how to recognize and respond to overdose, including with the use of nasal naloxone. Walley’s study reports that the deaths went down in places with the programs compared to places without, and that the reduction was significant in places that had a high level of implementation.

Meanwhile, the removal of legal and financing barriers to overdose programs continues to be a fairly hot item on state legislative agendas. How about every state getting on board? This would be a fine week for a series of “Dave Purchase Life Saver Acts.”

Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose. Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training. Family members and friends of opioid users can quickly get the drug into an overdosing user via injection or a nasal spray. In an accompanying editorial, top brass at NIDA and FDA sum up the news like this: the study

“represents a significant step in the evolution of the science in this area: a detailed analysis of the cost-effectiveness of overdose intervention with naloxone administration for heroin abusers. The authors suggest that lay naloxone administration is likely to be highly cost-effective in this setting, a robust finding that holds up under various assumptions. Future analyses that extend their findings to the setting of prescription opioids would be welcome.”

The editorial flags one of the major legal issues that gets in the way of wider naloxone distribution – its status as a prescription drug approved for use by injection. Changing this is a torturous regulatory process. In the short term, though, lawmakers can do a lot to get distribution going where it is needed. As of July of 2012, eight states had passed laws to clearly authorize or otherwise reduce legal barriers to the prescription of naloxone to drug users and other potential good Samaritans. That leaves 42 states where programs may have trouble operating out of concerns related to prescribing a drug for a lay person to administer. LawAtlas covers the law and has examples of the legislative approaches these states have taken.

One more thing: evidence that naloxone distribution looks to be cost-effective ought to motivate lawmakers to consider these programs. Many places don’t have them at all: a study published last year in MMWR reported, among other things, that “Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.” In others, programs are operating but with little or no public funding to purchase naloxone, whose price has been rising precipitously (that’s another story about our creaking system for producing essential medicines).

There’s so much we still don’t know about the prescription opioid problem. The partial remedies advanced so far reflect this:

Prescription Drug Monitoring Programs, which in essence define the problem as doctor-shopping patients;

treatment guidelines, which define the problem as doctors without expertise; and

crackdowns on “pill-mills,” which see the issue as physician corruption. Each of these diagnoses has an element of truth, but not necessarily enough to make the treatments effective.

One huge part of the problem has gotten far too little attention: the pharmaceutical supply chain where all these drugs start and along which they are distributed. Now, John Coleman, a former DEA officer, has given us a thorough and compelling primer on the supply chain, describing it and showing where the pressure points are for action. He is not happy about what he sees: DEA is overwhelmed, and too secretive with its data; and the distributors are too interested in profits and far too unwilling to police paying customers. But he also sees room for action and even hope. This article is well worth a read if you are interested in the overdose problem and how to solve it:

P.S. — One of the hopeful signs he sees was Florida’s legislation beefing up state-level monitoring and controls. This takes me back to the successful Wisconsin Cancer Pain Initiative in the 70s and 80s, which articulated the Principle of Balance in drug control and demonstrated that it was possible to have good access to pain medicine and effective control. In those days, David Joranson, the state drug controller, worked closely with DEA, using state regulatory authority to shut down docs and pharmacies who were acting outside the law. The possibility of history repeating itself is a ray of sunlight in the cloudy skies of this issue. (If you are interested in the story, here’s one place to start: Joranson, D., and J. L. Dahl. “Achieving Balance in Drug Policy: The Wisconsin Model.” In Advances in Pain Research and Therapy, edited by CS Hill Jr. and WS Fields. 197-204. New York: Raven Press, 1989.)